Trial Outcomes & Findings for The Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles (NCT NCT02548312)

Results Overview

Measured on a single-item 10-point Likert scale from (1) "not at all confident" to (10) "extremely confident". Higher scores indicate more confidence. Min score = 0, max score =10.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1065 participants

Primary outcome timeframe

Outcome measure will be assessed only at the time of the intervention (0 weeks). Readers will be asked to complete the study questionnaire immediately after reading the review article.

Results posted on

2019-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Dyspepsia Review- Competing Interest Statement 1 Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Gout Review- Competing Interest Statement 2 Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Dyspepsia Review- Competing Interest Statement 3 Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals	Dyspepsia Review- Competing Interest Statement 4 None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Gout Review- Competing Interest Statement 1 Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Dyspepsia Review- Competing Interest Statement 2 Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Gout Review- Competing Interest Statement 3 Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals..	Gout Review- Competing Interest Statement 4 None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.
Overall Study STARTED	133	133	134	133	133	133	133	133
Overall Study COMPLETED	100	90	96	87	99	93	93	91
Overall Study NOT COMPLETED	33	43	38	46	34	40	40	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dyspepsia Review- Competing Interest Statement 1 n=100 Participants Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Gout Review- Competing Interest Statement 2 n=90 Participants Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Dyspepsia Review- Competing Interest Statement 3 n=96 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals	Dyspepsia Review- Competing Interest Statement 4 n=87 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Gout Review- Competing Interest Statement 1 n=99 Participants Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Dyapepsia Review- Competing Interest Statement 2 n=93 Participants Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Gout Review- Competing Interest Statement 3 n=93 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals..	Gout Review- Competing Interest Statement 4 n=91 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Total n=749 Participants Total of all reporting groups
Age, Continuous	43.5 years n=5 Participants	45.5 years n=7 Participants	44.7 years n=5 Participants	42.8 years n=4 Participants	44.9 years n=21 Participants	42.9 years n=10 Participants	42.8 years n=115 Participants	42.9 years n=6 Participants	44 years n=6 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	46 Participants n=7 Participants	55 Participants n=5 Participants	45 Participants n=4 Participants	53 Participants n=21 Participants	51 Participants n=10 Participants	51 Participants n=115 Participants	51 Participants n=6 Participants	404 Participants n=6 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	44 Participants n=7 Participants	41 Participants n=5 Participants	42 Participants n=4 Participants	46 Participants n=21 Participants	42 Participants n=10 Participants	42 Participants n=115 Participants	40 Participants n=6 Participants	345 Participants n=6 Participants
Region of Enrollment United Kingdom	100 participants n=5 Participants	90 participants n=7 Participants	96 participants n=5 Participants	87 participants n=4 Participants	99 participants n=21 Participants	93 participants n=10 Participants	93 participants n=115 Participants	91 participants n=6 Participants	749 participants n=6 Participants
Type of doctor Consultant	31 Participants n=5 Participants	33 Participants n=7 Participants	35 Participants n=5 Participants	33 Participants n=4 Participants	37 Participants n=21 Participants	31 Participants n=10 Participants	34 Participants n=115 Participants	30 Participants n=6 Participants	264 Participants n=6 Participants
Type of doctor General practice	36 Participants n=5 Participants	34 Participants n=7 Participants	35 Participants n=5 Participants	29 Participants n=4 Participants	33 Participants n=21 Participants	34 Participants n=10 Participants	33 Participants n=115 Participants	29 Participants n=6 Participants	263 Participants n=6 Participants
Type of doctor Junior doctor	33 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	25 Participants n=4 Participants	29 Participants n=21 Participants	28 Participants n=10 Participants	26 Participants n=115 Participants	32 Participants n=6 Participants	222 Participants n=6 Participants

PRIMARY outcome

Timeframe: Outcome measure will be assessed only at the time of the intervention (0 weeks). Readers will be asked to complete the study questionnaire immediately after reading the review article.

Population: One participant in the Group 'Gout review- competing interest statement 2', one in 'Dyspepsia review- competing interest statement 2', one in 'Dyspepsia- statement 3', and one in 'Gout- statement 4' did not respond to the question related to the primary outcome. Hence, for this outcome the numbers analyzed= 89, 92, 95 and 90, respectively.

Measured on a single-item 10-point Likert scale from (1) "not at all confident" to (10) "extremely confident". Higher scores indicate more confidence. Min score = 0, max score =10.

Outcome measures

Outcome measures
Measure	Dyspepsia Review- Competing Interest Statement 1 n=100 Participants Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Gout Review- Competing Interest Statement 2 n=89 Participants Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Dyspepsia Review- Competing Interest Statement 3 n=95 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals	Dyspepsia Review- Competing Interest Statement 4 n=87 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Gout Review- Competing Interest Statement 1 n=99 Participants Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Dyspepsia Review- Competing Interest Statement 2 n=92 Participants Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Gout Review- Competing Interest Statement 3 n=93 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals..	Gout Review- Competing Interest Statement 4 n=90 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.
The Readers' Level of Confidence in the Conclusions Drawn in the Article.	6.2 score on a scale Interval 5.8 to 6.6	7.0 score on a scale Interval 6.7 to 7.4	6.1 score on a scale Interval 5.7 to 6.5	6.4 score on a scale Interval 6.0 to 6.8	7.1 score on a scale Interval 6.8 to 7.5	6.2 score on a scale Interval 5.8 to 6.6	7.4 score on a scale Interval 7.1 to 7.8	7.4 score on a scale Interval 7.0 to 7.8

SECONDARY outcome

Timeframe: Outcome measure will be assessed only at the time of the intervention (0 weeks)

Population: One participant in the Group 'Gout review- competing interest statement 4' and one participant in 'Dyspepasia review- competing interest statement 3' did not respond to the question related to this outcome. Hence, for this outcome the numbers analyzed= 90 and 95 respectively (n=91 and n=96 in the participant flow chart).

Measured on a single-item 10-point Likert scale from (1) "not at all important" to (10) "extremely important". Higher scores indicate more importance. Min score = 0, max score =10. Readers will be asked to complete the study questionnaire immediately after reading the review article.

Outcome measures

Outcome measures
Measure	Dyspepsia Review- Competing Interest Statement 1 n=100 Participants Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Gout Review- Competing Interest Statement 2 n=90 Participants Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Dyspepsia Review- Competing Interest Statement 3 n=95 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals	Dyspepsia Review- Competing Interest Statement 4 n=87 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Gout Review- Competing Interest Statement 1 n=99 Participants Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Dyspepsia Review- Competing Interest Statement 2 n=93 Participants Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Gout Review- Competing Interest Statement 3 n=93 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals..	Gout Review- Competing Interest Statement 4 n=90 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.
Importance of the Article.	6.3 score on a scale Interval 6.0 to 6.7	6.4 score on a scale Interval 6.1 to 6.8	6.3 score on a scale Interval 5.9 to 6.7	6.3 score on a scale Interval 5.9 to 6.7	6.9 score on a scale Interval 6.6 to 7.3	6.5 score on a scale Interval 6.2 to 6.9	6.7 score on a scale Interval 6.4 to 7.1	7.0 score on a scale Interval 6.6 to 7.4

SECONDARY outcome

Timeframe: Outcome measure will be assessed only at the time of the intervention (0 weeks)

Population: One participant in the Group 'Dyspepsia review- competing interest statement 2', 'Dyspepsia review- statement 3', 'Gout review- statement 4' did not respond to the question related to this outcome. Hence, for this outcome the numbers analyzed= 92, 90 and 95 respectively (however n=93, 91 and 96 in participant flowchart).

Measured on a single-item 10-point Likert scale from (1) "not at all interesting" to (10) "extremely interesting". Higher scores indicate more interest. Min score = 0, max score =10. Readers will be asked to complete the study questionnaire immediately after reading the review article.

Outcome measures

Outcome measures
Measure	Dyspepsia Review- Competing Interest Statement 1 n=100 Participants Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Gout Review- Competing Interest Statement 2 n=90 Participants Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Dyspepsia Review- Competing Interest Statement 3 n=95 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals	Dyspepsia Review- Competing Interest Statement 4 n=87 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Gout Review- Competing Interest Statement 1 n=99 Participants Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Dyspepsia Review- Competing Interest Statement 2 n=92 Participants Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Gout Review- Competing Interest Statement 3 n=93 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals..	Gout Review- Competing Interest Statement 4 n=90 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.
Interest in the Article.	5.9 score on a scale Interval 5.5 to 6.3	6.2 score on a scale Interval 5.9 to 6.6	5.8 score on a scale Interval 5.4 to 6.2	5.8 score on a scale Interval 5.4 to 6.2	6.7 score on a scale Interval 6.5 to 7.0	6.0 score on a scale Interval 5.6 to 6.4	6.5 score on a scale Interval 6.2 to 6.9	7.0 score on a scale Interval 6.7 to 7.4

SECONDARY outcome

Timeframe: Outcome measure will be assessed only at the time of the intervention (0 weeks)

Population: Analysis only includes subset that indicated they currently treat gout/dyspepsia and own practice differed from recommendations given in the review.

Measured on a single-item 10-point Likert scale from (1) "not at all likely" to (10) "extremely likely". Higher scores indicate more likely to change practice. Min score = 1, max score =10. Readers asked to complete the study questionnaire immediately after reading the review article.

Outcome measures

Outcome measures
Measure	Dyspepsia Review- Competing Interest Statement 1 n=20 Participants Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Gout Review- Competing Interest Statement 2 n=17 Participants Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Dyspepsia Review- Competing Interest Statement 3 n=29 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals	Dyspepsia Review- Competing Interest Statement 4 n=12 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.	Gout Review- Competing Interest Statement 1 n=16 Participants Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.	Dyspepsia Review- Competing Interest Statement 2 n=19 Participants Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member.	Gout Review- Competing Interest Statement 3 n=11 Participants Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals..	Gout Review- Competing Interest Statement 4 n=15 Participants None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests.
Number of Participants Who Are Extremely Likely to Change Practice on the Basis of the Article (Scored a "10"), for Those Currently Treating the Relevant Condition	0 Participants	4 Participants	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants	3 Participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Sara Schroter

BMJ

Phone: 02073836744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place